FDA Approves Cymbalta for Fibromyalgia

INDIANAPOLIS, June 16, 2008 /PRNewswire-FirstCall/ -- The U.S.
Food and Drug Administration (FDA) has approved Cymbalta (duloxetine HCl) for the management of fibromyalgia, a chronic
widespread pain disorder, Eli Lilly and Company announced today.
Cymbalta is the first serotonin- norepinephrine reuptake inhibitor
with proven efficacy for reducing pain in patients with
fibromyalgia. The fibromyalgia indication represents the second
FDA-approved use for Cymbalta for a pain disorder, demonstrating
the medication's analgesic effect.

"The approval of Cymbalta is important because it provides
physicians and patients with a new treatment option shown to help
reduce pain and improve functioning in this difficult-to-treat
disorder," said Madelaine Wohlreich, M.D., medical advisor and
research physician at Lilly.

The cause of fibromyalgia remains unknown; however, scientists
believe it may be related to some combination of changes in brain
and spinal cord chemistry,(i) genetics(ii) and stress(iii). Some
researchers believe fibromyalgia is a disorder of increased
sensitivity to pain. Although the way Cymbalta works in people is
not fully known, medical experts believe it increases the activity
of two naturally occurring substances called serotonin and
norepinephrine. These substances aid communication in many areas of
the brain and spinal cord that affect emotion. Research also
suggests that these substances are part of the body's natural
pain-suppressing system.

"The FDA approval of Cymbalta for the management of fibromyalgia
is another important step in the efforts to ensure that people with
fibromyalgia will have the availability of effective medications to
help reduce the chronic, widespread pain of this life-altering
disorder," said Lynne Matallana, president of the National
Fibromyalgia Association and a fibromyalgia patient.

Fibromyalgia is estimated to affect 2 percent of the U.S.
population - approximately 5 million people - the majority of those
diagnosed being women.(iv),(v) The disorder is characterized by
chronic widespread pain and tenderness. Some patients may have
additional symptoms.(i) Although there is no known cure for
fibromyalgia, some physicians recommend a comprehensive care plan
that can include education, medication, and lifestyle changes to
help manage the symptoms of the disorder.(i)

"In fibromyalgia, there is no one-size-fits-all approach to
managing the disorder," said Dan Clauw, M.D., professor of medicine
in the Division of Rheumatology and director of the Chronic Pain
and Fatigue Research Center at the .

The approval marks the fourth disorder that the FDA has approved
for Cymbalta. In addition to fibromyalgia, Cymbalta is approved for
the management of diabetic peripheral neuropathic pain (DPNP) and
the treatment of major depressive disorder and generalized anxiety
disorder, all in adults age 18 years and older.

Additional important changes have been made to the Cymbalta
prescribing information, including updates to the Warnings and
Precautions section. Full prescribing information can be found at
www.cymbalta.com.

Data Highlights

Lilly established the efficacy of Cymbalta in two pivotal
three-month clinical trials involving 874 patients with
fibromyalgia. In both studies, Cymbalta reduced pain at study
endpoint compared with placebo as measured by the Brief Pain
Inventory (BPI) 24-hour average pain scale.(vi),(vii) The BPI is a
scale that measures the severity of pain.

Significant improvement in pain for Cymbalta vs. placebo was
observed in the first week of each study. Fifty-one percent and 55
percent of patients on Cymbalta had a 30 percent improvement on the
BPI at endpoint (clinically meaningful relief is considered at
least 30 percent pain reduction(viii)).

In addition, 65 percent and 66 percent of patients taking
Cymbalta 60 mg daily reported feeling better at endpoint as
measured by the Patient Global Impression of Improvement (PGI-I).
The PGI-I is a patient-rated scale that evaluates how much
improvement has occurred since beginning treatment.

Cymbalta 60 mg was superior to placebo on the Fibromyalgia
Impact Questionnaire (FIQ) Total Score. The FIQ is a scale that is
used to assess and evaluate the impact of fibromyalgia on aspects
of health and functioning believed to be most affected by the
disorder.

About Cymbalta

Serotonin and norepinephrine in the brain and spinal cord are
believed to both mediate core mood symptoms and help regulate the
perception of pain. Based on preclinical studies, Cymbalta is a
balanced and potent reuptake inhibitor of serotonin and
norepinephrine that is believed to potentiate the activity of these
chemicals in the central nervous system (brain and spinal cord).
While the mechanism of action of Cymbalta is not fully known,
scientists believe its effects on depression and anxiety symptoms,
as well as its effect on pain perception, may be due to increasing
the activity of serotonin and norepinephrine in the central nervous
system.

Cymbalta is approved in the United States for the acute and
maintenance treatment of major depressive disorder, the acute
treatment of generalized anxiety disorder, and the management of
fibromyalgia and diabetic peripheral neuropathic pain in adults age
18 years and older. Cymbalta is not approved for use in pediatric
patients.

Important Safety Information

Cymbalta is approved to treat major depressive disorder and
generalized anxiety disorder, and to manage diabetic peripheral
neuropathic pain and fibromyalgia. Antidepressants can increase
suicidal thoughts and behaviors in children, adolescents, and young
adults. Patients should call their doctor right away if they
experience new or worsening depression symptoms, unusual changes in
behavior, or thoughts of suicide. Be especially observant within
the first few months of treatment or after a change in dose.
Cymbalta is approved only for adults 18 and over.

Cymbalta is not for everyone. Patients should not take Cymbalta
if they have recently taken a type of antidepressant called a
monoamine oxidase inhibitor (MAOI), are taking Mellaril(R)
(thioridazine), or have uncontrolled glaucoma. Patients should
speak with their doctor about any medical conditions they may have
including kidney problems, glaucoma, or diabetes. Patients should
talk to their doctor if they have itching, right upper belly pain,
dark urine, yellow skin or eyes, or unexplained flu-like symptoms,
which may be signs of liver problems. Severe liver problems,
sometimes fatal, have been reported. They should also talk to their
doctor about alcohol consumption. Patients should tell their doctor
about all their medicines, including those for migraine, to avoid a
potentially life-threatening condition. Taking Cymbalta with NSAID
pain relievers, aspirin, or blood thinners may increase bleeding
risk. Patients should consult with their doctor before stopping
Cymbalta or changing the dose and if they are pregnant or
nursing.

Patients taking Cymbalta may experience dizziness or fainting
upon standing. The most common side effects of Cymbalta include
nausea, dry mouth, sleepiness, and constipation. This is not a
complete list of side effects.

If patients have any questions, they should talk to their doctor
before taking Cymbalta.

About Eli Lilly and Company

Lilly, a leading innovation-driven corporation, is developing a
growing portfolio of first-in-class and best-in-class
pharmaceutical products by applying the latest research from its
own worldwide laboratories and from collaborations with eminent
scientific organizations. Headquartered in Indianapolis, Ind.,
Lilly provides answers - through medicines and information - for
some of the world's most urgent medical needs. Additional
information about Lilly is available at www.lilly.com.

P-LLY

This press release contains forward-looking statements about the
potential of Cymbalta for the management of fibromyalgia, and
reflects Lilly's current beliefs. However, as with any
pharmaceutical product, there are substantial risks and
uncertainties in the process of development and commercialization.
There is no guarantee that the product will continue to be
commercially successful. For further discussion of these and other
risks and uncertainties, see Lilly's filings with the United States
Securities and Exchange Commission. Lilly undertakes no duty to
update forward-looking statements.

(iv) Lawrence, et al. "Estimates of the Prevalence of Arthritis
and Other Rheumatic Conditions in the United States." Arthritis and
Rheumatism. 2008; 58(1):31.

(v) Wolfe, F, et al. "The Prevalence and Characteristics of
Fibromyalgia in the General Population." Arthritis and Rheumatism.
1995; 38(1):19-28.

(vi) Arnold, L. et al. "A Randomized, Double-Blind, Placebo
Controlled Trial of Duloxetine in the Treatment of Women with
Fibromyalgia With or Without Major Depressive Disorder." Pain.
2005; 119:14.

(vii) Russell IJ, et al. "Efficacy and Safety of Duloxetine for
Treatment of Fibromyalgia in Patients With or Without Major
Depressive Disorder: Results From A Six-Month, Randomized,
Double-Blind, Placebo-Controlled, Fixed-Dose Trial," Pain. 2008: In
Press.